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Exparel vs Marcaine for Pain Management After Knee Replacement
N/A
Waitlist Available
Research Sponsored by Rothman Institute Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients at least 18 years old who have primary unilateral TKA for osteoarthritis performed at Thomas Jefferson University Hospital.
Be older than 18 years old
Must not have
Body weight<50 Kg, BMI>40 Kg/m2
Renal disease (contraindication for NSAIDs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Summary
This trial is testing whether Exparel is better than Marcaine at controlling pain and reducing side effects related to narcotics while also considering patient satisfaction and outcomes measures. The investigators will also analyze whether the higher price of Exparel is worth it based on factors like decreased need for postoperative pain medication and physical therapy.
Who is the study for?
This trial is for adults over 18 who need a knee replacement due to osteoarthritis at Thomas Jefferson University Hospital. It's not for those with severe anesthesia risks, kidney or liver disease, certain drug allergies, low blood pressure history, extreme body weight issues, recent substance abuse, or chronic opioid use.
What is being tested?
The study compares Exparel and Marcaine as pain management drugs after knee surgery. It looks at how well they control pain, affect narcotic use and side effects, patient satisfaction and recovery outcomes including hospital stay length and physical therapy needs.
What are the potential side effects?
Possible side effects of Exparel and Marcaine include reactions at the injection site like swelling or pain; systemic reactions such as nausea or vomiting; nerve damage symptoms like numbness; allergic responses; and potential impact on heart rate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and had a knee replacement at Thomas Jefferson University Hospital due to arthritis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I weigh less than 50 kg or my BMI is over 40.
Select...
I cannot take certain pain relievers due to kidney disease.
Select...
I cannot take acetaminophen due to liver disease.
Select...
I cannot have injections into my spinal fluid.
Select...
I am currently taking MAO inhibitors or tricyclic antidepressants.
Select...
I have been using opioid medications regularly for the last month.
Select...
I have a history of low blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: MarcaineActive Control1 Intervention
Group II: ExparelActive Control1 Intervention
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Who is running the clinical trial?
Rothman Institute OrthopaedicsLead Sponsor
126 Previous Clinical Trials
22,584 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh less than 50 kg or my BMI is over 40.I cannot take certain pain relievers due to kidney disease.I cannot take acetaminophen due to liver disease.I had complications like infection or mechanical failure within 6 weeks after my knee surgery.I am allergic or cannot take certain pain medications like oxycodone or morphine.I have been diagnosed with fibromyalgia.I cannot have injections into my spinal fluid.I am currently taking MAO inhibitors or tricyclic antidepressants.I have a history of low blood pressure.I am over 18 and had a knee replacement at Thomas Jefferson University Hospital due to arthritis.I have been using opioid medications regularly for the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Marcaine
- Group 2: Exparel
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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